[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04445285":3,"trial-entities:NCT04445285":141,"trial-summary:NCT04445285":145},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":50,"sex":67,"minimum_age":68,"maximum_age":17,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":74,"locations":77,"central_contacts":97,"overall_officials":104,"references":105,"see_also_links":140},"NCT04445285","USAH 1002 000","Phase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure","Double Blind Randomized Phase 2 Placebo Controlled Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure","RECRUITING","2022-02-28","2021-05","2021-05-28","2020-04-28","Jon Simmons","OTHER",true,"This Phase 2 Randomized Placebo Controlled Trial will determine if administering nebulized Dornase Alpha (rhDNase) to COVID-19 patients with respiratory failure is safe and will reduce 28-day mortality.",null,[19],"Covid19",[21],"Covid-19, Coronavirus","INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},44,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Pulmozyme\u002F Recombinant human deoxyribonuclease (rh-DNase)","2.5mg Pulmozyme\u002F Recombinant human deoxyribonuclease (rh-DNase) aerosolized treatment once every 24 hours for five (5) consecutive days; a total of five (5) doses",[35],"Treatment Arm",{"type":31,"name":37,"description":38,"armGroupLabels":39},"0.9%sodium chloride","Placebo of 0.9% sodium chloride every 24 hours for five (5) consecutive days; a total of 5 doses",[40],"Placebo Arm 0.9% sodium chloride",[42,46],{"measure":43,"description":44,"timeFrame":45},"Mortality at 28 days","All Cause Mortality at 28 days","28 days after enrollment",{"measure":47,"description":48,"timeFrame":49},"Systemic Therapeutic Response","To assess the effect of Pulmozyme® on the severity of respiratory failure, systemic inflammatory response, and multi-organ failure.","5 days after enrollment",[51,55,58,61,63],{"measure":52,"description":53,"timeFrame":54},"Respiratory Response","Proportion of patients alive and free of invasive mechanical ventilation at 28 days invasive mechanical ventilation at 28 days","28 days",{"measure":56,"description":57,"timeFrame":54},"Legnth of ICU Stay","Proportion of patients alive and discharged from the ICU at 28 days discharged from the ICU at 28 days",{"measure":59,"description":60,"timeFrame":54},"Legnth of Hospital Stay","Proportion of patients alive and discharged from the hospital at 28 days",{"measure":52,"description":62,"timeFrame":54},"Alive, respiratory failure-free days at 28 days",{"measure":64,"description":65,"timeFrame":66},"Pulmonary Function","Pulmonary Function Ratio at 5 days","5 days","ALL","18 Years",false,{"inclusion":71,"exclusion":72,"raw_text":73},[],[],"Inclusion Criteria:\n\n1. Male or Female age 18 or older\n2. On high flow oxygen =\u002F\\> 6 liters nasal cannula (or)\n3. On mechanical ventilation\n4. Clinical diagnosis of COVID-19 \\& positive PCR test (or)\n5. Clinical diagnosis of COVID-19 \\& negative PCR test with clinical symptoms of COVID-19 and pathognomonic lesions on a chest CT scan\n\nExclusion Criteria:\n\n1. Known allergy to Pulmozyme\n2. Less than 18 years of age\n3. Grave condition with anticipated death within 48 hours; at the discretion of treating physician.\n4. Enrollment in another clinical trial receiving investigatory drugs",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"status":8,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":94},"University of South Alabama","Mobile","Alabama","36617","United States",[85,90],{"name":86,"role":87,"phone":88,"email":89},"Jon Simmons, M.D.","CONTACT","251-471-7971","jsimmons@health.southalabama.edu",{"name":91,"role":87,"phone":92,"email":93},"Wendy Blount, RN, MSN","251-445-9834","wlblount@health.southalabama.edu",{"lat":95,"lon":96},30.69436,-88.04305,[98,102],{"name":99,"role":87,"phone":100,"email":101},"Jon D Simmons, M.D.","12514459834","jdsimmons@health.southalabama.edu",{"name":91,"role":87,"phone":103,"email":93},"2514554566",[],[106,110,113,116,119,122,125,128,131,134,137],{"pmid":107,"type":108,"citation":109},"23979273","BACKGROUND","Simmons JD, Lee YL, Mulekar S, Kuck JL, Brevard SB, Gonzalez RP, Gillespie MN, Richards WO. Elevated levels of plasma mitochondrial DNA DAMPs are linked to clinical outcome in severely injured human subjects. Ann Surg. 2013 Oct;258(4):591-6; discussion 596-8. doi: 10.1097\u002FSLA.0b013e3182a4ea46.",{"pmid":111,"type":108,"citation":112},"20203610","Zhang Q, Raoof M, Chen Y, Sumi Y, Sursal T, Junger W, Brohi K, Itagaki K, Hauser CJ. Circulating mitochondrial DAMPs cause inflammatory responses to injury. Nature. 2010 Mar 4;464(7285):104-7. doi: 10.1038\u002Fnature08780.",{"pmid":114,"type":108,"citation":115},"24748601","Schumacker PT, Gillespie MN, Nakahira K, Choi AM, Crouser ED, Piantadosi CA, Bhattacharya J. Mitochondria in lung biology and pathology: more than just a powerhouse. Am J Physiol Lung Cell Mol Physiol. 2014 Jun 1;306(11):L962-74. doi: 10.1152\u002Fajplung.00073.2014. Epub 2014 Apr 18.",{"pmid":117,"type":108,"citation":118},"25795724","Kuck JL, Obiako BO, Gorodnya OM, Pastukh VM, Kua J, Simmons JD, Gillespie MN. Mitochondrial DNA damage-associated molecular patterns mediate a feed-forward cycle of bacteria-induced vascular injury in perfused rat lungs. Am J Physiol Lung Cell Mol Physiol. 2015 May 15;308(10):L1078-85. doi: 10.1152\u002Fajplung.00015.2015. Epub 2015 Mar 20.",{"pmid":120,"type":108,"citation":121},"12060578","Dobson AW, Grishko V, LeDoux SP, Kelley MR, Wilson GL, Gillespie MN. Enhanced mtDNA repair capacity protects pulmonary artery endothelial cells from oxidant-mediated death. Am J Physiol Lung Cell Mol Physiol. 2002 Jul;283(1):L205-10. doi: 10.1152\u002Fajplung.00443.2001.",{"pmid":123,"type":108,"citation":124},"20969951","Ruchko MV, Gorodnya OM, Zuleta A, Pastukh VM, Gillespie MN. The DNA glycosylase Ogg1 defends against oxidant-induced mtDNA damage and apoptosis in pulmonary artery endothelial cells. Free Radic Biol Med. 2011 May 1;50(9):1107-13. doi: 10.1016\u002Fj.freeradbiomed.2010.10.692. Epub 2010 Oct 20.",{"pmid":126,"type":108,"citation":127},"21890512","Chouteau JM, Obiako B, Gorodnya OM, Pastukh VM, Ruchko MV, Wright AJ, Wilson GL, Gillespie MN. Mitochondrial DNA integrity may be a determinant of endothelial barrier properties in oxidant-challenged rat lungs. Am J Physiol Lung Cell Mol Physiol. 2011 Dec;301(6):L892-8. doi: 10.1152\u002Fajplung.00210.2011. Epub 2011 Sep 2.",{"pmid":129,"type":108,"citation":130},"23154780","Gebb SA, Decoux A, Waggoner A, Wilson GL, Gillespie MN. Mitochondrial DNA damage mediates hyperoxic dysmorphogenesis in rat fetal lung explants. Neonatology. 2013;103(2):91-7. doi: 10.1159\u002F000342632. Epub 2012 Nov 15.",{"pmid":132,"type":108,"citation":133},"23241530","Hashizume M, Mouner M, Chouteau JM, Gorodnya OM, Ruchko MV, Potter BJ, Wilson GL, Gillespie MN, Parker JC. Mitochondrial-targeted DNA repair enzyme 8-oxoguanine DNA glycosylase 1 protects against ventilator-induced lung injury in intact mice. Am J Physiol Lung Cell Mol Physiol. 2013 Feb 15;304(4):L287-97. doi: 10.1152\u002Fajplung.00071.2012. Epub 2012 Dec 14.",{"pmid":135,"type":108,"citation":136},"27787436","Simmons JD, Freno DR, Muscat CA, Obiako B, Lee YL, Pastukh VM, Brevard SB, Gillespie MN. Mitochondrial DNA damage associated molecular patterns in ventilator-associated pneumonia: Prevention and reversal by intratracheal DNase I. J Trauma Acute Care Surg. 2017 Jan;82(1):120-125. doi: 10.1097\u002FTA.0000000000001269.",{"pmid":138,"type":108,"citation":139},"11350811","Grishko V, Solomon M, Wilson GL, LeDoux SP, Gillespie MN. Oxygen radical-induced mitochondrial DNA damage and repair in pulmonary vascular endothelial cell phenotypes. Am J Physiol Lung Cell Mol Physiol. 2001 Jun;280(6):L1300-8. doi: 10.1152\u002Fajplung.2001.280.6.L1300.",[],{"nct_id":4,"conditions":142,"biomarkers":144},[143],"COVID-19 Infection",[],{"nct_id":4,"found":15,"summary":146,"prompt_version":156},{"design":147,"status":148,"heading":149,"summary":150,"follow_up":151,"word_count":152,"commitments":153,"compensation":154,"drugs_mentioned":155},"This is a Phase 2 randomized, placebo-controlled study, meaning participants are randomly assigned to receive either the study drug or a placebo. It plans to include 44 participants.","completed","Phase 2 Trial of Pulmozyme for COVID-19 Respiratory Failure","This Phase 2 study is testing if a medicine called Pulmozyme (recombinant human deoxyribonuclease or rh-DNase) can help reduce deaths in people with COVID-19 who are experiencing breathing problems. Participants will receive either Pulmozyme or a placebo (an inactive substance like salt water) through a nebulizer (a device that turns liquid medicine into a mist to be inhaled) once a day for five days. The study is looking to see if Pulmozyme is safe and if it lowers the number of deaths 28 days after starting treatment, and how well people respond to the treatment after 5 days. You might be able to join if you are 18 or older, have COVID-19, and are on high-flow oxygen or a breathing machine. The current status of this study is unclear, and it plans to enroll 44 people.","The study will measure mortality at 28 days after enrollment and systemic therapeutic response at 5 days after enrollment.",136,"Participants will receive either Pulmozyme or a placebo through a nebulizer once every 24 hours for five consecutive days, for a total of five doses.","Not stated in the trial record.",[],"v2"]